Local Study Associate Director - Oncology Madrid EUR 50.000 - 70.000 To lead Local Study Team(s) (LSTs) at the country level to deliver committed components of clinical studies according to agreed resources, budget, and timelines, while complying with AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations. In addition to leading LST(s), the Local Study Associate Director (LSAD) may perform site monitoring as needed to support the flexible capacity model. The LSAD is responsible for ensuring that sites are identified, site qualifications performed, set up, initiated, monitored, closed, and documentation archived. LSADs might have different internal titles based on experience level (LSAD, Senior LSAD). The experience level depends on years of experience, performance record, level of independence, ability to take on additional tasks, or tutor more junior colleagues. The Director, Country Head, Senior Director, Country Head may assign this internal title after confirmation with Senior Director, Cluster Head / Executive Director, Regional Head. Typical Accountabilities Has the overall responsibility for the study commitments within the country and for timely delivery of data to the required quality. Leads Local Study Team consisting of CRA(s), CSA(s) for assigned study/studies. Leads and optimizes the performance of the Local Study Team(s) at the country level, ensuring compliance with AZ Procedural Documents, ICH-GCP, and local regulations. Ensures, as required, that clinical and operational feasibility assessments of potential studies are performed to the highest quality. Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks. Ensures timely submission of applications/documents to EC/IRB at start-up and throughout the study, working with Regulatory Affairs for timely submissions to Regulatory Authorities. Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains an accurate study budget in AZ's financial system through regular checks. Prepares local Master CSA (including site budget) and amendments as needed. Prepares country-level Master Informed Consent Form (MICF) and site-level ICFs, including translations, in line with AZ SOPs and local regulations. Ensures all country and site-level trial essential documents required by ICH-GCP are collected and verified before site enrollment, in line with AZ SOPs. Plans and coordinates applicable local drug activities, from purchase or reimbursement to destruction. Sets up and maintains the study in CTMS at the country level and on local websites as required by law. Oversees, manages, and coordinates monitoring activities from site activation to study closure, following Monitoring Plans. Reviews monitoring visit reports and advises monitors on study-related matters. Performs co-monitoring, accompanied site visits, and training with CRAs. Proactively identifies risks and facilitates resolution of complex study problems and issues. Organizes regular Local Study Team meetings. Works towards building good relationships with team members, site staff, and stakeholders. Reports study progress to the Global Study Associate Director/Team and SMM Lead. Contributes to patient recruitment strategies and communicates with investigators. Develops and reviews risk management plans at the country level. Communicates regularly with National Lead Investigators on recruitment and study matters. Plans and leads National Investigator meetings as required. Assists in forecasting study timelines, resources, recruitment, budget, materials, and drug supplies. Ensures systems for safety reporting, regulatory submissions, and clinical trial transparency are set up and accessible. Ensures accurate payments are performed according to regulations. Participates in training and coaching new team members, ensuring compliance with ICH-GCP and AZ procedures. Ensures completeness and proper archiving of study documents in the eTMF. Prepares for audits and inspections in collaboration with CQAD and QA. Provides input for process improvements. Reports to Line Managers on study milestones and performance. Ensures compliance with local policies and ethics. Provides feedback on research activities relevant to the local market. Ensures adherence to AZ's Code of Ethics and company policies on people, finance, technology, security, and SHE. Collaborates with Medical Affairs and supports SMM initiatives. People Management Responsibility Direct reports: I Indirect reports: Approximately 0 Span of Influence Operates in: Own country or small clusters 2-3 countries Global Education, Qualifications, Skills, and Experience Bachelor degree in life sciences or related field, or equivalent. Minimum 3 years of experience in Development Operations (CRA, SrCRA) or related fields. Good knowledge of ICH-GCP and local regulations. Proven leadership and motivation skills for cross-functional teams. Excellent project management, organizational, communication, and interpersonal skills. Ability to prioritize, handle multiple tasks, and attention to detail. Willingness to travel nationally and internationally. Cell Therapy experience (≥3 years), Hematology experience (≥5 years), or related therapeutic expertise. Experience as a clinical project manager or similar role (>5 years). English C1 or higher. Strong communication, networking, resilience, negotiation, and adaptability skills. Ability to work independently and contribute to strategy. Key Stakeholders and Relationships Internal: Local Study Team, Global Study Team, Line Managers, Clinical Quality, Medical Affairs, Regulatory, Patient Safety. External: Date Posted: 23-may-2025 Closing Date: 10-jun-2025 AstraZeneca promotes diversity and equal opportunity. We welcome applications from all qualified candidates and comply with applicable non-discrimination laws. J-18808-Ljbffr